Breast CancerMARHABANCT03081507
Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City
A study testing SM-LHW and PN-LHW in people with Breast Cancer and Cervical Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
Studies have reported Muslims in the US and NYC face numerous language and healthcare access barriers. This is a randomized randomized controlled design will be used to test the efficacy of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical cancer screening among Muslim women… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer
- What is being tested?
- SM-LHW and PN-LHW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 28 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identify as Muslim
- female
- residence in a NYC borough
- self-report as having received a mammogram more than two years ago and are age 40-74 years
- self-report having received a Pap test more than three years ago and are age 40-65 years
Who cannot join
- Report a past or current diagnosis of breast or cervical cancer
- Report having had a hysterectomy
- Report having had breast reconstructive surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10017
About this study
Studies have reported Muslims in the US and NYC face numerous language and healthcare access barriers. This is a randomized randomized controlled design will be used to test the efficacy of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical cancer screening among Muslim women age 40 - 75 years living in NYC. Study participants will be randomized to an Lay Health Workers (LHW) led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW). A specific aim of the study is to develop, implement and evaluate the efficacy of a two-arm, randomized control trial designed to increase receipt of breast and/or cervical cancer screening among Muslim women aged 40 -75 years in New York City (NYC).
Read the detailed description
The goal of this study, entitled Muslim Americans Reaching for Health and Building Alliances (MARHABA), is to evaluate the effectiveness of a culturally patient navigation (PN) intervention designed for Muslim women to increase breast and cervical cancer screening participation.
- Conditions
- Breast Cancer, Cervical Cancer
- Being tested
- SM-LHW, PN-LHW
- Keywords
- Muslim Americans, Patient Navigation, Breast Cancer, Cervical Cancer
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-LHWBehavioural
Will not receive additional follow-up from the LHW, but will be encouraged during the session to make an appointment with their provider to schedule a mammogram and Pap test, or to consult the MARHABA webpage for information on low-cost and culturally appropriate referral sources of screening. Individuals assigned to this arm who did not attend an educational seminar will be mailed a packet containing a palm card, brochure, and letter encouraging them to speak with their provider about breast and cervical cancer screening and/or going to the MARHABA webpage. LHWs will complete a follow-up survey with participants by phone or in-person at 4 months after baseline
PN-LHWBehavioural
PNLHW participants will receive three planned contacts with LHWs that focus on navigation for obtaining mammogram and/or Pap testing.The initial contact will be made by phone and will focus on motivating participants to make an appointment with their primary care provider and/or obstetrician/gynecologist (OB/GYN), as well as provide information on low-cost or free care if necessary. The second contact will discuss the process of going to the appointment and the third contact will focus on the process of obtaining and interpreting. The second and third contacts will be either made by phone or in-person, depending on participant needs.
| Study group | Role | What they receive |
|---|---|---|
| LHW-led small media intervention arm (SM-LHW) | Experimental | Not described Receives: Behavioral: SM-LHW |
| LHW-led plus small media intervention arm (PN-LHW) | Experimental | Not described Receives: Behavioral: PN-LHW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of Pap Test
Pap test awareness is a positive response to the following question: "Have you ever heard of a 'Pap test'?"
Measured: 5 Months
Awareness of Mammogram
Awareness is a positive response to the following question: "Have you ever heard of a 'mammogram'?"
Measured: 5 Months
Pap test receipt
Pap test receipt is defined as a positive response to "Have you ever had a 'Pap test'?" after describing the test. For "no" responses, we defined Pap test intention as a positive response to "Are you planning on obtaining a 'Pap test'?"
Measured: 5 Months
Mammogram test receipt
Mammogram test receipt is defined as a positive response to "Have you ever had a 'Mammogram'?" after describing the test. For "no" responses, we defined Mammogram test intention as a positive response to "Are you planning on obtaining a 'Mammogram'?"
Measured: 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Mar 2017
- Primary completion20 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomized to an LHW-led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW) upon determination of study eligibility and informed consent procedures.
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081507
- Sponsor's protocol ID
- 16-00803
- Acronym
- MARHABA
- Status last verified
- Dec 2018
- First submitted
- 10 Mar 2017
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wyatt LC, Chebli P, Patel S, Alam G, Naeem A, Maxwell AE, Raveis VH, Ravenell J, Kwon SC, Islam NS. A Culturally Adapted Breast and Cervical Cancer Screening Intervention Among Muslim Women in New York City: Results from the MARHABA Trial. J Cancer Educ. 2023 Apr;38(2):682-690. doi: 10.1007/s13187-022-02177-5. Epub 2022 May 19.
PubMed 35585475
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muslim Americans Reaching for Health and Building Alliances (MARHABA): Patient Navigation Intervention to Increase Breast and Cervical Cancer Screening Among Muslim Women in New York City
- ClinicalTrials.gov ID
- NCT03081507
- Acronym / sponsor ID
- MARHABA / 16-00803
- Conditions
- Breast Cancer, Cervical Cancer
- Keywords
- Muslim Americans, Patient Navigation, Breast Cancer, Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies have reported Muslims in the US and NYC face numerous language and healthcare access barriers. This is a randomized randomized controlled design will be used to test the efficacy of a Patient Navigation (PN) intervention to increase participation in breast and/or cervical cancer screening among Muslim women age 40 - 75 years living in NYC. Study participants will be randomized to an Lay Health Workers (LHW) led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW). A specific aim of the study is to develop, implement and evaluate the efficacy of a two-arm, randomized control trial designed to increase receipt of breast and/or cervical cancer screening among Muslim women aged 40 -75 years in New York City (NYC).
Detailed description
The goal of this study, entitled Muslim Americans Reaching for Health and Building Alliances (MARHABA), is to evaluate the effectiveness of a culturally patient navigation (PN) intervention designed for Muslim women to increase breast and cervical cancer screening participation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be randomized to an LHW-led small media intervention arm (SM-LHW) or a LHW-led patient navigation plus small media intervention arm (PN-LHW) upon determination of study eligibility and informed consent procedures.
| Arm | Type | Receives |
|---|---|---|
| LHW-led small media intervention arm (SM-LHW) | Experimental | Behavioral: SM-LHW |
| LHW-led plus small media intervention arm (PN-LHW) | Experimental | Behavioral: PN-LHW |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-identify as Muslim
- female
- residence in a NYC borough
- self-report as having received a mammogram more than two years ago and are age 40-74 years
- self-report having received a Pap test more than three years ago and are age 40-65 years
Key exclusion criteria (3 listed)
- Report a past or current diagnosis of breast or cervical cancer
- Report having had a hysterectomy
- Report having had breast reconstructive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM-LHWWill not receive additional follow-up from the LHW, but will be encouraged during the session to make an appointment with their provider to schedule a mammogram and Pap test, or to consult the MARHABA webpage for information on low-cost and culturally appropriate referral sources of screening. Individuals assigned to this arm who did not attend an educational seminar will be mailed a packet containing a palm card, brochure, and letter encouraging them to speak with their provider about breast and cervical cancer screening and/or going to the MARHABA webpage. LHWs will complete a follow-up survey with participants by phone or in-person at 4 months after baseline | Behavioural | LHW-led small media intervention arm (SM-LHW) |
| PN-LHWPNLHW participants will receive three planned contacts with LHWs that focus on navigation for obtaining mammogram and/or Pap testing.The initial contact will be made by phone and will focus on motivating participants to make an appointment with their primary care provider and/or obstetrician/gynecologist (OB/GYN), as well as provide information on low-cost or free care if necessary. The second contact will discuss the process of going to the appointment and the third contact will focus on the process of obtaining and interpreting. The second and third contacts will be either made by phone or in-person, depending on participant needs. | Behavioural | LHW-led plus small media intervention arm (PN-LHW) |
Primary outcome
Awareness of Pap Test
Time frame: 5 Months
Pap test awareness is a positive response to the following question: "Have you ever heard of a 'Pap test'?"
Awareness of Mammogram
Time frame: 5 Months
Awareness is a positive response to the following question: "Have you ever heard of a 'mammogram'?"
Pap test receipt
Time frame: 5 Months
Pap test receipt is defined as a positive response to "Have you ever had a 'Pap test'?" after describing the test. For "no" responses, we defined Pap test intention as a positive response to "Are you planning on obtaining a 'Pap test'?"
Mammogram test receipt
Time frame: 5 Months
Mammogram test receipt is defined as a positive response to "Have you ever had a 'Mammogram'?" after describing the test. For "no" responses, we defined Mammogram test intention as a positive response to "Are you planning on obtaining a 'Mammogram'?"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Derived from this study: PubMed 35585475Wyatt LC, Chebli P, Patel S, Alam G, Naeem A, Maxwell AE, Raveis VH, Ravenell J, Kwon SC, Islam NS. A Culturally Adapted Breast and Cervical Cancer Screening Intervention Among Muslim Women in New York City: Results from the MARHABA Trial. J Cancer Educ. 2023 Apr;38(2):682-690. doi: 10.1007/s13187-022-02177-5. Epub 2022 May 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Islam principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SM-LHW and PN-LHW in people with Breast Cancer and Cervical Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness of Pap Test (time frame: 5 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.